The Cartagena Protocol on Biosafety: Key Implementation Issues

Laura M. Reifschneider

Introduction
In January 2000, four years of intense and difficult negotiations concluded with the adoption of the Cartagena Protocol on Biosafety. As the first round of discussions about Protocol implementation begins, however, the atmosphere may prove at least as contentious and politically charged as in the past. This is because a number of critical issues, such as the documentation requirements for commodity shipments and the question of whether to establish a liability regime, were deferred in the end to permit agreement on a final text. In addition, even fully negotiated items, such as the precautionary principle language, are susceptible to vastly different interpretations. This article identifies some of the key outstanding issues to be resolved as the Protocol moves from theory into practice.

Background and Process for Implementation of the Biosafety Protocol
The Biosafety Protocol is a legally binding instrument that aims to "contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements." Thus the primary, but not exclusive, function of the Protocol is environmental protection with respect to living genetically modified organisms or "LMOs" moving in international trade. The Protocol seeks to accomplish its objective mainly through requiring informed consent from importing countries prior to the first importation of a new LMO that is intended for release into the environment of the importing country.

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...an intergovernmental committee ("ICCP") has been formed to formulate recommendations concerning implementation of the Protocol.

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The Biosafety Protocol officially opened for signature in May 2000 in Nairobi, at the biennial conference of its parent agreement, the Convention on Biological Diversity ("CBD"). Only signatories to the CBD are permitted to sign and ratify it. Once the Protocol becomes effective, following the fiftieth ratification, meetings of the parties to the Protocol will begin to occur in conjunction with the conferences of the parties to the CBD.

The European Union ("EU"), in particular, is pushing for prompt ratification of the Protocol so that it may take effect early in 2002. This would permit the first Meeting of the Parties to the Protocol ("MOP-1") to be held in connection with the next CBD conference ("COP-6"), to be held in May 2002 in The Hague. It also would coincide with "Rio Plus Ten," an international gathering scheduled for 2002 that will commemorate the tenth anniversary of the Rio Earth Summit where the CBD was launched, thus demonstrating another "success" in the field of environmental protection and sustainable development since Rio.

In the meantime, an intergovernmental committee ("ICCP") has been formed to formulate recommendations concerning implementation of the Protocol. The first meeting of the ICCP ("ICCP-1") will take place December 11-15, 2000 in Montpellier, France with a second meeting tentatively scheduled for October 2001 in Montreal. Once the Protocol takes effect, the ICCP will present its recommendations to the Parties at MOP-1 and then will cease to exist. Only the Parties to the Protocol will be empowered to make decisions on the ICCP recommendations and any other implementation issues.

Major Outstanding Issues Awaiting Negotiation

Documentation Requirements for Commodities
At present, the Protocol requires that shipments of LMOs intended for direct use as food, for feed or for processing ("LMO-FFPs"), e.g., commodity grains, be accompanied by documentation that clearly identifies that the shipment "may contain" LMOs. Within two years of the Protocol entering into force, however, the Parties to the Protocol are to decide on the "detailed requirements" for such shipments, including "specification of their identity and any unique identification" of the LMO-FFPs. Given the widely divergent views, laws, and practices around the world on documentation, this is likely to prove the most divisive of the many implementation issues.

Handling, Transport, Packaging and Identification Requirements
In addition to the specific documentation requirements for LMO-FFPs, the Protocol requires that Parties consider the need for, and modalities of, developing standards with respect to identification, handling, packaging and transport of LMOs generally covered by the Protocol. The Protocol does not impose a time limit for considering these additional documentation requirements but requires that the Parties take into account work done by other international bodies. This includes, inter alia, standards set by the various transport organizations such as the International Civil Aviation Organization, the International Maritime Organization, and the Universal International Postal Union as well as the codes and guidelines established by other United Nations organizations such as the World Health Organization and the Food and Agricultural Organization.

Establishment of Compliance Mechanisms
One of the key outstanding questions for practical implementation of the Protocol is how to ensure compliance with its procedures and mechanisms. This issue is to be taken up at MOP-1 but no time limit is set for its resolution.

While many have focused on the need to ensure compliance by governments and companies seeking to export LMOs, the other side of compliance, namely, ensuring that governments to whom such shipments are to be made meet their own obligations, including timely decision making,

is critical to the free flow of trade. Other aspects of compliance and enforcement include whether to establish dispute resolution mechanisms and/or penalties in cases of non-compliance.

Consideration of the Need for a Liability Regime
The contentious issue of liability was resolved in the Protocol negotiations by the inclusion of an "enabling clause" that requires further discussion of, but does not necessarily pre-judge, the issue. Specifically, this clause mandates that the Parties adopt at MOP-1 a process for the "appropriate elaboration of international rules and procedures" for liability and redress for damage resulting from the transboundary movement of LMOs. According to the Protocol, the Parties should endeavor to complete this process within four years.

As is usually the case, efforts to "appropriately elaborate" rules for liability and redress for the Protocol must take into account other ongoing processes in international law on liability. One such process is that underway in the CBD, where the more general question of liability for damage to biodiversity must, but has yet to, be discussed in depth. To kick off discussions on this topic for the CBD, which may well converge with the process to be adopted for the Protocol, France will host an informal meeting in the second half of 2001.

Priority Implementation Issues for ICCP-1

Information Sharing
While numerous aspects of the Protocol require further attention, countries and observers alike are in agreement that one of the highest immediate priorities is to make the Biosafety Clearing House ("BCH") operational as soon as possible. This is necessary not only to ensure information sharing among all interested stakeholders but also to allow the operation of the procedures in the Protocol with respect to the movement of LMO-FFPs. At an initial meeting of experts, it was determined that the BCH could and should be operational, at least at a minimal configuration, by the second meeting of the ICCP. The experts also decided that the BCH should contain only publicly available information, thus avoiding altogether the need to secure confidential information. The BCH is required, under the terms of the Protocol, to be fully operational by MOP-1, with subsequent reviews, based on experience with implementation of the Protocol, to take place periodically thereafter. A host of other issues, from technical requirements to development of common formats and the determination of responsibility for erroneous information, still need to be addressed.

Capacity Building
At least as important to the effective implementation of the Protocol as the BCH is capacity building. Issues to be addressed include ascertaining the current needs of countries, identifying past and ongoing capacity building programs, and determining what approach should be taken in light of identified needs and existing work in this area. One of the key questions to be resolved concerns the functioning of a so-called "roster of experts" which is comprised of biosafety experts nominated by governments to provide advice and other support, including assistance with risk assessment and decision making, for developing countries and those with economies in transition. At issue is who may call upon this body under what circumstances, how confidential information can be protected while also ensuring transparency in the process, and to what extent non-governmental experts may participate in providing advice and assistance.

Mechanisms for Decision Making
A final issue to be taken up in the first tranche of implementation talks concerns the establishment of mechanisms to facilitate decision-making by importing parties. These mechanisms are to be agreed at MOP-1.

Other Key Implementation Issues

Application of the Precautionary Principle
Under the Protocol, LMOs that are intentionally introduced into the environment of another country require consent from the importing country prior to the first shipment in accordance with the Protocol’s Advanced Informed Agreement ("AIA") procedure. The Protocol subjects LMO-FFPs to a different procedure that involves publication of approvals for LMO-FFPs on the BCH and responses by potential countries of import. In both cases, the precautionary principle, as formulated below, applies:

Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of Import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of that [LMO or LMO-FFP], in order to avoid or minimize such potential adverse effects.

Given the invocation of the precautionary principle by EU Member States to justify their ongoing moratoria on certain genetically modified organisms, some fear the uses to which this provision may be put. Ultimately, however, the validity of a country’s decision to withhold consent for a shipment of LMOs under the Protocol based on this language will be tested and determined in light of countries’ rights and obligations under the relevant World Trade Organization agreements.

Application of the Advanced Informed Agreement Procedure
As described above, the Protocol requires compliance with the AIA procedure prior to the "first intentional transboundary movement of [an LMO] for intentional introduction into the environment of the Party of import." LMOs merely in transit through a country or destined for contained use are not subject to the AIA mechanism. Contained use is defined in the Protocol as follows:

Any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.

The term "intentional introduction" is not defined except to the extent that the Protocol states that LMOs intended for direct use as food or feed or for processing does not constitute an intentional introduction into the environment. Accordingly, the line between what constitutes "contained use" on the one hand and "intentional introduction into the environment" on the other is not clear. Indeed, it would appear that a large grey area exists in which one could reasonably argue that a particular LMO falls within the definition of contained use and therefore is excluded from the AIA requirements while another might consider it an "intentional introduction." The exact parameters of contained use and the precise triggers for application of the AIA mechanism will only be determined on a case-by-case basis once implementation of the Protocol begins.